Healthy VolunteersPhase 1NCT01775904
A Study of Two Dosage Forms of LY2886721 in Healthy Participants
A Phase 1 study testing LY2886721 in a Capsule and LY2886721 in an orally disintegrating tablet (ODT) in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY2886721 in a Capsule and LY2886721 in an orally disintegrating tablet (ODT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to May 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive, at screening
- At least 4 participants who are greater than 55 years of age
- Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product
- Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone [FSH] level greater than 40 milli-international units per milliliter [mIU/mL])
- Have venous access sufficient to allow for blood sampling as per the protocol
Who cannot join
- Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated, within the last 30 days, in a clinical trial involving an investigational product
- Have known allergies to LY2886721, related compounds, or any components of the formulation
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have a significantly abnormal blood pressure as determined by the investigator
- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Show all 11Show fewer
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Show evidence of hepatitis B or C and/or positive hepatitis B or C antibody
- Have a history of, or current, significant ophthalmologic disease
- Show evidence of significant active neuropsychiatric disease or history of suicide attempt
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, 53704
About this study
Official title: A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.
This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.
- Conditions
- Healthy Volunteers
- Being tested
- LY2886721 in a Capsule, LY2886721 in an orally disintegrating tablet (ODT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2886721 in a CapsuleDrug
Administered orally.
LY2886721 in an orally disintegrating tablet (ODT)Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| LY2886721 Capsule (water, fasting) | Experimental | Reference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. Receives: Drug: LY2886721 in a Capsule |
| LY2886721 ODT (no water, fasting) | Experimental | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. Receives: Drug: LY2886721 in an orally disintegrating tablet (ODT) |
| LY2886721 ODT (water, fed) | Experimental | A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods. Receives: Drug: LY2886721 in an orally disintegrating tablet (ODT) |
| LY2886721 ODT (water, fasting) | Experimental | A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods. Receives: Drug: LY2886721 in an orally disintegrating tablet (ODT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721
Measured: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721
Measured: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721
Measured: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721
Measured: Baseline through 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775904
- Sponsor's protocol ID
- 14249
- Other IDs
- I4O-MC-BACG
- Status last verified
- May 2019
- First submitted
- 23 Jan 2013
- Last updated
- 19 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Capsule and Orally Disintegrating Tablet and to Determine the Effect of Food and Water on the Pharmacokinetics of LY2886721 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01775904
- Acronym / sponsor ID
- 14249
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate two different formulations of LY2886721. In addition, this study will determine how much of study drug (LY2886721) gets into the blood steam and how long the body takes to get rid of it after taking each formulation with or without a meal. Information about any side effects that may occur will also be collected. Each participant may be involved in the study for approximately 7 weeks.
This study requires 4 periods. In each period, participants will receive LY2886721 as a tablet or capsule, with or without food and water. There is a 7 day washout between each period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY2886721 Capsule (water, fasting) | Experimental | Drug: LY2886721 in a CapsuleReference formulation. A single oral dose of 70 milligrams (mg) LY2886721 in a capsule given with water and without a meal in one of four periods. |
| LY2886721 ODT (no water, fasting) | Experimental | Drug: LY2886721 in an orally disintegrating tablet (ODT)A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given without water and without a meal in one of four periods. |
| LY2886721 ODT (water, fed) | Experimental | Drug: LY2886721 in an orally disintegrating tablet (ODT)A single oral dose of a 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and after a high-fat breakfast in one of four periods. |
| LY2886721 ODT (water, fasting) | Experimental | Drug: LY2886721 in an orally disintegrating tablet (ODT)A single oral dose of 70 mg LY2886721 in an orally disintegrating tablet (ODT) given with water and without a meal in one of four periods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive, at screening
- At least 4 participants who are greater than 55 years of age
- Male participants: Agree to use a reliable method of birth control and not donate sperm during the study and for 3 months following the last dose of the investigational product
- Female participants: Women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy, hysterectomy, or both) confirmed by medical history, or postmenopausal females, as determined by medical history and physical examination (spontaneous amenorrhea for 6 to 12 months and a follicle stimulating hormone [FSH] level greater than 40 milli-international units per milliliter [mIU/mL])
- Have venous access sufficient to allow for blood sampling as per the protocol
Key exclusion criteria (11 listed)
- Are currently enrolled in, have completed, or discontinued within the last 30 days from a clinical trial involving an investigational product; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have participated, within the last 30 days, in a clinical trial involving an investigational product
- Have known allergies to LY2886721, related compounds, or any components of the formulation
- Have an abnormality in the 12-lead electrocardiogram (ECG)
- Have a significantly abnormal blood pressure as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2886721 in a CapsuleAdministered orally. | Drug | LY2886721 Capsule (water, fasting) |
| LY2886721 in an orally disintegrating tablet (ODT)Administered orally. | Drug | LY2886721 ODT (no water, fasting), LY2886721 ODT (water, fasting), LY2886721 ODT (water, fed) |
Primary outcome
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721
Time frame: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721
Time frame: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721
Time frame: Baseline through 96 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721
Time frame: Baseline through 96 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2886721 in a Capsule and LY2886721 in an orally disintegrating tablet (ODT) in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721 (time frame: Baseline through 96 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.